Health Trials

Clinical trials

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Status: Not yet recruiting

A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)

The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.

Participants needed: 228
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Nurami Medical LtdUpdated: Aug 14, 2026
Eligibility criteria

Male or female aged ≥18 and <80 years. [+6]

Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural... [+23]

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Status: Not yet recruiting

Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.

Participants needed: 20
Trial details
Age: 22-65Biological sex: AllType: InterventionalSponsor: Nurami Medical LtdUpdated: Aug 14, 2025
Eligibility criteria

Subject between the ages of 22-65 (inclusive) [+4]

Subject has known hydrocephalus. [+19]

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